scholarly journals Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-month Neurodevelopment Follow-up of a Randomized Clinical Trial

2019 ◽  
Author(s):  
Kathryn E Hopperton ◽  
Deborah L O'Connor ◽  
Nicole Bando ◽  
Aisling M Conway ◽  
Dawn V Y Ng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Milk ◽  
Randomized Clinical Trial ◽  
Bovine Milk ◽  
Mean Difference ◽  
Donor Milk ◽  
Mother's Milk ◽  
Adjusted Scores ◽  
Composite Scores

Abstract Background Bovine milk-based fortifiers (BMBF) have been standard of care for nutrient fortification of feeds for very low birthweight (VLBW) infants, however there is increasing use of human milk-based fortifiers (HMBF) in neonatal care despite additional costs and limited supporting data. No randomized clinical trial has followed infants fed these fortifiers after initial hospitalization. Objective To compare neurodevelopment in infants born weighing <1250 g fed mother's milk with supplemental donor milk and either a HMBF or BMBF. Methods This is a follow-up of a completed pragmatic, triple-blind, parallel randomized clinical trial conducted in Southern Ontario between August 2014 and March 2016 (NCT02137473) with feeding tolerance as the primary outcome. Infants weighing <1250 g at birth were block randomized by an online third-party service to receive either HMBF (n = 64) or BMBF (n = 63) added to mother's milk with supplemental donor milk during hospitalization. Neurodevelopment was assessed at 18-months corrected age using the Bayley Scales of Infant and Toddler Development, Third Edition. Follow-up was completed October 2017. Results Of the 127 infants randomized, 109 returned for neurodevelopmental assessment. No statistically significant differences between fortifiers were identified for cognitive composite scores (adjusted scores 94.7 in the HMBF group and 95.9 in the BMBF group; fully adjusted mean difference, −1.1 [95% CI: −6.5 to 4.4]), language composite scores (adjusted scores 92.4 in the HMBF group and 93.1 in the BMBF; fully adjusted mean difference, −1.2 [−7.5 to 5.1]), or motor composite scores (adjusted scores 95.6 in the HMBF group and 97.7 in the BMBF; fully adjusted mean difference, −1.1 [−6.3 to 4.2]). There was no difference in the proportion of participants that died or had neurodevelopmental impairment or disability between groups. Conclusions Providing HMBF compared to BMBF does not improve neurodevelopment scores at 18-months corrected age in infants born <1250 g otherwise fed a human milk diet. Trial Registration: NCT02137473, clinicaltrials.gov.

scholarly journals Nutrient enrichment of human milk with human and bovine milk–based fortifiers for infants born weighing <1250 g: a randomized clinical trial

2018 ◽  
Vol 108 (1) ◽  
pp. 108-116 ◽  
Author(s):  
Deborah L O'Connor ◽  
Alex Kiss ◽  
Christopher Tomlinson ◽  
Nicole Bando ◽  
Ann Bayliss ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Human Milk ◽  
Randomized Clinical Trial ◽  
Nutrient Enrichment ◽  
Bovine Milk ◽  
Fecal Calprotectin ◽  
Mortality And Morbidity ◽  
Morbidity Index ◽  
Feeding Tolerance

ABSTRACT Background Human milk-based fortifiers (HMBFs) are being adopted in neonatal care to enrich the nutrients in human milk for very low birth weight (VLBW) infants despite being costly and there being limited efficacy data. No randomized clinical trial has evaluated the use of HMBF compared with bovine milk–based fortifiers (BMBFs) in the absence of formula feeding. Objective To determine if HMBF compared with BMBF for routine nutrient enrichment of human milk improves feeding tolerance, reduces morbidity, reduces fecal calprotectin (a measure of gut inflammation), and supports the growth of infants &lt;1250 g. Design In this blinded randomized clinical trial, infants born weighing &lt;1250 g were recruited from neonatal units in Ontario, Canada between August 2014 and November 2015. The infants were fed mother's milk and donor milk as required. Fortification commenced at 100 mL/kg per day of HMBF (0.81 kcal/mL) or BMBF (0.72 kcal/mL) and advanced at 140 mL/kg per day to 0.88 and 0.78 kcal/mL, respectively. The primary outcome was percentage of infants with a feeding interruption for ≥12 h or a &gt;50% reduction in feeding volume. Secondary outcomes included a dichotomous mortality and morbidity index (i.e., affirmative for any one of death, late-onset sepsis, necrotizing enterocolitis, chronic lung disease, or severe retinopathy of prematurity), fecal calprotectin, and growth. Results Of 232 eligible infants, 127 (54.7%) were randomized (n = 64 HMBF, n = 63 BMBF). Mean ± SD birth weight and gestational age of infants were 888 ± 201 g and 27.7 ± 2.5 wk, respectively. No statistically significant differences were identified in feeding interruptions [17/64 HMBF, 20/61 BMBF; unadjusted risk difference: −6.2% (95% CI: −22.2%, 9.8%)]. There was no statistically significant difference in the mortality and morbidity index (35.9% HMBF, 49.2% BMBF, adjusted P = 0.07), changes in fecal calprotectin, or growth z scores. Conclusions Among infants born weighing &lt;1250 g and exclusively fed human milk, the use of HMBF did not improve feeding tolerance or reduce mortality and morbidity compared with BMBF. This trial was registered at clinicaltrials.gov as NCT02137473.

scholarly journals The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3807
Author(s):  
Chiara Peila ◽  
Elena Spada ◽  
Sonia Deantoni ◽  
Ester Iuliano ◽  
Guido E. Moro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Milk ◽  
Preterm Infants ◽  
Bovine Milk ◽  
Wilcoxon Test ◽  
Protein Supplement ◽  
Donkey Milk ◽  
Neurodevelopmental Outcomes

Adequate nutrition is fundamental to neonatal survival and short-term outcomes, but it also has long-term consequences on quality of life and neurologic development of preterm infants. Donkey milk has been suggested as a valid alternative for children allergic to cows’ milk proteins, due to its biochemical similarity to human milk; we, hence, hypothesized that donkey milk could be a suitable basis for developing an innovative human milk fortifier for feeding preterm infants. The aim of the current study was to extend the findings and to evaluate the neurodevelopmental outcomes at 18 months of corrected age of the infants enrolled in the clinical trial named “Fortilat”. Infants born ≤1500 g and <32 weeks of gestational age were randomized to receive either a combination of bovine milk-based multicomponent fortifier and protein supplement or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The followed fortification protocol was the same for the two groups and the two diets were designed to be isoproteic and isocaloric. All infants enrolled were included in a developmental assessment program. The neurodevelopmental assessment was performed at 18 ± 6 months of corrected age. Minor and major neurodevelopmental impairment and General Quotient (GQ) at the Griffiths-II Mental Development Scale were considered. The GQ was considered both in continuous and as two classes: lower than and higher than (or equal to) a defined cutoff (GQcl). The difference in GQ and GQcl between the two arms was estimated using Mann–Whitney–Wilcoxon test or Fischer exact test, respectively, on the assumption of casual loss at follow-up. A further analysis was performed using generalized linear models. There were 103 children (bovine milk-derived fortifier arm = 54, donkey milk-derived fortifier arm = 49) included for the neurodevelopmental follow-up. All observations were included in the interval of 18 ± 6 months of corrected age. No significant difference was observed between the two arms in the incidence of neurologic sequelae and the GQs were similar in the two arms. Our results demonstrated no difference for the donkey milk-derived fortifier compared to standard bovine-derived fortifier regarding long-term neurodevelopmental outcomes.

scholarly journals Correction: Impact on Patients' Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial

PLoS ONE ◽  
2016 ◽  
Vol 11 (5) ◽  
pp. e0156471
Author(s):  
Anete Trajman ◽  
Betina Durovni ◽  
Valeria Saraceni ◽  
Alexandre Menezes ◽  
Marcelo Cordeiro-Santos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Outcomes ◽  
Randomized Clinical Trial ◽  
Stepped Wedge
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